FDA-Device2020-11-25Class II
Class IV New Era medical laser device
Inova Lasers LLC
Hazard
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
Sold states
US Nationwide Distribution
Affected count
8 units
Manufactured in
433 5th Ave Fl 6, N/A, New York, NY, United States
Products
Class IV New Era medical laser device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0440-2021Don't want to check this manually?
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